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Is It COVID or the Flu? Take This FDA-Approved, At-Home Test to Find Out
You don't need a prescription to purchase a test that will tell you whether you're sick with COVID or the flu.
FDA approves first ever medication for obstructive sleep apnea — here's what that means
Tirzepatide is the active ingredient in Zepbound, the FDA approved prescription medicine for Obstructive Sleep Apnea.
FDA issues first draft guidance on use of AI in drug, medical device development
Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released ...
Off-brand versions of Lilly weight loss drug must be pulled off market, could mean higher prices
The United States Food and Drug Administration says the shortage of Eli Lilly’s Zepbound and Mounjaro drugs has been resolved ...
BioPharma Dive1d
5 FDA decisions to watch in the first quarter of 2025
By the end of March, the regulator could clear a highly anticipated pain drug from Vertex and a heart drug that’s critical to Alnylam’s future.
BioSpace1d
5 FDA Decisions to Watch in Q1
Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy ...
Rezolute Receives Breakthrough Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism
Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital ...
CBS News10d
FDA proposes new tests to detect asbestos in cosmetics and other products containing talc
a medical doctor and director of the FDA's Office of Cosmetics and Colors, said Thursday in a news release announcing the agency's action. The agency's proposed rule falls short of a ban on talc ...
FDA proposes new testing rules to ensure cosmetics are asbestos-free
The Food and Drug Administration is proposing a rule that cosmetic companies would have to take extra steps to ensure that ...
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025Cyprium is eligible to receive royalties and up to $129 ...
Cingulate secures capital ahead of 2025 plans to submit drug for FDA approval
A KCK pharmaceutical company gets a cash injection that should sustain it long enough to get an ADHD drug to the FDA for ...
HealthDay on MSN3d
FDA approves Gemtesa for overactive bladder in men with BPH
Gemtesa is approved for men with overactive bladder symptoms who are receiving pharmacologic treatment for benign prostatic hyperplasia.